The RejuvatoneMD device is a non-invasive at-home facial stimulation device intended for cosmetic use. The device works by delivering low-level electrical microcurrent impulses through dual contact spheres to strategic locations on the face and allows users to adjust the output level for personalized comfort.

AI/ML Overview

Here's an analysis of the provided text regarding the RejuvatoneMD device's acceptance criteria and studies, organized according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for performance of the device in its intended cosmetic use (e.g., "90% of users report improved skin tone"). Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and manufacturing standards.

The table below summarizes the technical characteristics comparison between the RejuvatoneMD (Subject Device) and its predicate (NuFACE® Mini Device). For performance specifications like maximum output voltage/current, pulse duration, frequency, etc., the "acceptance" is implied by demonstrating values that are similar to and within an acceptable range of the predicate device, and crucially, comply with IEC 60601-2-10 requirements.

Element of Comparison	Acceptance Criteria (Implied by Substantial Equivalence and Standards)	Reported RejuvatoneMD Performance
Intended Use	Facial stimulation for over-the-counter cosmetic use, equivalent to predicate.	Intended for facial stimulation and indicated for over-the-counter cosmetic use.
Electrical Safety	Compliance with IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012.	Complies with IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012. Patient Leakage Current: NC 60μA, SFC 360μA. (Predicate: 56μA, 374μA)
Performance Standard	Compliance with IEC 60601-2-10 Edition 2.0 2012-06.	Complies with IEC 60601-2-10 Edition 2.0 2012-06.
EMC	Compliance with IEC 60601-1-2 Edition 3: 2007-03.	Complies with IEC 60601-1-2 Edition 3: 2007-03.
Biocompatibility	Direct patient contact materials comply with ISO10993-5 and ISO10993-10.	All user directly contacting materials comply with ISO10993-5 and ISO10993-10 requirements.
Usability/Label Comprehension	At least 95% of participants able to correctly self-select, complete comprehension, and perform device use based on labeling.	Reported Performance: Over 95% of 30 participants were able to: Correctly Self-Select the device, Correctly complete the Comprehension portion, and Correctly perform the Device Use portion of the study.
Output Characteristics	Values for maximum output voltage/current, pulse duration/frequency, net charge, phase charge, current density, power density, and burst mode must be comparable to the predicate and fall within the safety limits defined by IEC 60601-2-10.	Maximum Output Voltage: 256mV@500Ω (Predicate: 222mV), 806mV@2KΩ (Predicate: 781mV), 4.02V@10KΩ (Predicate: 3.90V). Maximum Output Current: 512µA @ 500Ω (Predicate: 396µA), 403µA @ 2KΩ (Predicate: 395µA), 403µA @ 10KΩ (Predicate: 391µA). Pulse Duration: ON phase: 60 ms (Predicate: 60.4 ms), OFF phase: 60 ms (Predicate: 60.4 ms), Total Pulse Width: 120 ms (Predicate: 120.8 ms). Pulse Frequency: 8.33Hz (Predicate: 8.28 Hz). Net Charge (per pulse): 0µC @ 500Ω (Predicate: 1.43µC). Maximum Phase Charge: 24.18µC @ 500Ω (Predicate: 23.7µC). Maximum Current Density: 0.498mA/cm²@500Ω (Predicate: 0.514mA/cm²). Maximum Average Power Density: 32.77µW/cm² @500Ω (Predicate: 99.05µW/cm²). Burst Mode (Pulses per burst): 20 (Predicate: 20). Bursts per second: 8.33 (Predicate: 8.28). Burst duration (seconds): 2.4 (Predicate: 2.42). Duty Cycle: 20 (Predicate: 20). All deemed "very close to the predicate device in these areas and within an acceptable range" and comply with IEC 60601-2-10.

2. Sample Size Used for the Test Set and Data Provenance

Usability/Label Comprehension Study:
- Sample Size: 30 participants
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies it was a prospective study conducted specifically for this device validation.
Other Testing (Electrical Safety, Performance, EMC, Biocompatibility): These tests are typically laboratory-based and use technical samples of the device and its components, not human subjects, except for biocompatibility which is tested on materials. No sample size of specific user data is applicable here. The data provenance is laboratory testing against recognized standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

For the Usability/Label Comprehension Study, the ground truth was based on the participants' ability to correctly self-select, comprehend instructions, and use the device. This "ground truth" is a measure of user understanding and performance, not a clinical diagnosis or expert consensus on clinical outcomes. No external "experts" (like radiologists) are mentioned as establishing ground truth for this usability study. The study itself assesses whether lay users can achieve the intended "truth" of understanding and proper use.
For the technical standards compliance (Electrical Safety, Performance, EMC, Biocompatibility), the "ground truth" is the established requirements and limits defined by the international consensus standards (IEC, ISO). The experts involved would be the engineers and technicians performing the tests and the standard-setting bodies, not individual experts assessing specific cases.

4. Adjudication Method for the Test Set

For the Usability/Label Comprehension Study, the "adjudication method" was based on whether participants could "correctly" perform specific tasks. This would have been predetermined criteria defined in the study protocol (e.g., "User correctly identifies appropriate use for the device" or "User correctly selects power level"). It's not an expert adjudication in the sense of clinical disagreement.
For technical testing, compliance is typically determined by measurements falling within specified ranges or passing defined test procedures. There is no "adjudication" in the clinical sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This device is a direct-to-consumer microcurrent facial stimulator, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

A standalone performance was done, but not in the context of an "algorithm." The core of the submission relies on the standalone electrical and mechanical performance of the device as measured against international safety and performance standards (IEC, ISO). The device's technological characteristics are compared directly to the predicate device. The usability study is also a form of standalone performance assessment – how well does a human user interact with the device as designed.

7. The Type of Ground Truth Used

Usability/Label Comprehension Study: User performance and comprehension against pre-defined correct actions and understanding gleaned from the labeling.
Technical Performance (Electrical Safety, EMC, Biocompatibility): Compliance with international consensus standards (IEC, ISO) and comparison of technical specifications to the legally marketed predicate device. This is primarily objective, measurable physical parameters.
Substantial Equivalence: Comparison to the technological characteristics, intended use, and safety profile of a legally marketed predicate device (K133823 – NuFace Mini).

8. The Sample Size for the Training Set

Not applicable. This device is hardware for electrical stimulation. There is no "training set" in the machine learning sense. The device's design and parameters are based on established electrical engineering principles and the specifications of predicate devices.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set. The "ground truth" for the device's design parameters is derived from engineering principles, safety standards, and established performance of similar predicate devices.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 23, 2016

Trophy Skin, Inc. % Sue Anthoney-Dewet FDA Consultant Aegis Regulatory, Inc. 2424 Dempster Drive Coralville, IA 52241

Re: K152199

Trade/Device Name: RejuvatoneMD Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: February 17, 2016 Received: February 23, 2016

Dear Ms. Anthoney-Dewet:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K152199

Device Name RejuvatoneMD

Indications for Use (Describe)

The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K152199

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR § 807.92

Date Prepared: March 23, 2016

1. Submitter Information: AEGIS Regulatory, Inc. – Susan Anthoney-DeWet 2424 Dempster Drive Coralville, IA 52241 Tel.: 865-982-5552 Email: bob@fdalistingconsultants.com

On Behalf of Sponsor: Trophy Skin, Inc.

Attn: Imran Karim, President 4372 Kenmare Trail Frisco, TX 75034 Phone: (469) 233-1768 Email: imran@trophyskin.com

2. General Information

2.1 Classification Name: Transcutaneous Electrical Nerve Stimulator for Aesthetic Purposes

2.2 Common/Usual Name: TENS Device
2.3 Proprietary Names: RejuvatoneMD
2.4 Classification: Class II
2.5 Classification Number: 882.5890
2.6 Review Panel: Neurology
2.6 Product Code: NFO

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3. Device Description:

4. Indications / Intended Use:

The RejuvatoneMD is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

Rx or OTC:

The labeling, instructions, and User Operations (21 CFR § 801.60 and 61), are designed for layman understanding and use. The predicate devices are indicated for (OTC) use.

5. Predicate Device:

The RejuvatoneMD device is substantially equivalent in design, function and intended use to the following predicate device:

K133823 – NuFace Mini (Carol Cole Company)

6. Technological Characteristics and Substantial Equivalence

The technological characteristics of the RejuvatoneMD device and the predicate device, are substantially equivalent in that both devices are designed to provide electrical stimulation to the facial skin for cosmetic use. The RejuvatoneMD and the predicate device function using the same mode of action by producing microcurrent that is discharged through electrodes that are in contact with the patient's skin, and both have user adjustable settings . The technical characteristics and physical presented in this submission demonstrate that the RejuvatoneMD device is substantially equivalent in design, function and intended use to the predicate device.

Sections below compare the characteristics of the RejuvatoneMD and the predicate device:

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Elements of Comparison	Subject Device	Predicate Device
Device Name and Model	RejuvatoneMD, Model: TSTONEMD	NuFACE® Mini Device
510(k) Number	Applying	K133823
Product Code	NFO	NFO
Manufacturer	Trophy Skin, Inc.	Carol Cole Company
Intended Use	This device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.	The NuFACE® Mini Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Power Source(s)	9V battery (Type: 6LR61)	2 rechargeable AA NiMH batteries
Applied Part	Type BF	Type BF
Patient Leakage Current	NC 60μAComply with IEC 60601-1 and IEC 60601-2-10	56μAComply with IEC 60601-1 and IEC 60601-2-10
	SFC 360μAComply with IEC 60601-1 and IEC 60601-2-10	374μAComply with IEC 60601-1 and IEC 60601-2-10
Average DC current through electrodes when device is on but no pulses are being applied	0A	--
Number of Output Channels	One channel	One channel
Number of Output Modes	1 mode	1 mode
Output Intensity Level	5 steps	3 steps
Synchronous or Alternating?	N/A - 1 Output Channel	N/A - 1 Output Channel
Method of Channel Isolation	N/A - 1 Output Channel	N/A - 1 Output Channel
Regulated Current or Regulated Voltage?	Both	Both
Elements of Comparison	Subject Device	Predicate Device
Software/Firmware/Microprocessor Control?	Yes	Yes
Automatic Overload Trip	Not required due to circuit design	Not required due to circuit design
Automatic No-Load Trip	No	Yes
Automatic Shut Off	Yes	Yes
Patient Override Control	Yes	Yes
Indicator On/Off Status	Yes	Yes
Display Low Battery	No	Yes
Voltage/ Current Level	Yes	Yes
Timer Range	Yes (20 minutes)	Yes (21 minutes)
LCD Display	No	No
Compliance with Voluntary Standards	YesComply with IEC 60601-1 and IEC 60601-2-10, IEC 60601-1-2	YesComply with IEC 60601-1 and IEC 60601-1-2
Biocompatibility	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.
Compliance* with 21 CFR 898	Yes	Yes
Main Unit Weight	248g	816g
Dimensions	55.0mm x 35.0mm x 177.2mm (L x W x H)	2.5" W x 4.2" L x 1.2" D
Electrode Size	0.81cm²	--
Housing Materials and Construction	Housing made from ABS plastic and output contacts made from ACD12 Chrome.	Thermo Plastic
Environment for operating	Temperature: 5 ~ 45°	Temperature: 5 ~ 40° C
Elements of Comparison	Subject Device	Predicate Device
	Humidity: 20 ~ 65% RH	Humidity: 20 ~ 65% RH
Environment for storage	Temperature: 0 ~ 45°	Temperature: 0 ~ 40° C
	Humidity: 10 ~ 90% RH	Humidity: 10 ~ 90% RH
Waveform	Pulsed Monophasic	Pulsed Monophasic
Shape	Modulated Square	Modulated Square
Maximum OutputVoltage(+/- 10%)	256mV@500Ω	222mV@ 500Ω
	806mV@2KΩ	781mV@ 2KΩ
	4.02V@10KΩ	3.90V@ 10KΩ
Maximum OutputCurrent(+/- 10%)	512µA @ 500Ω	396µA @ 500Ω
	403µA @ 2KΩ	395µA @ 2KΩ
	403µA @ 10KΩ	391µA @10KΩ
Pulse Duration	ON phase: 60 ms	ON phase: 60.4 ms
	OFF phase: 60 ms	OFF phase: 60.4 ms
	Total Pulse Width: 120 ms	Total Pulse Width: 120.8ms
Pulse Frequency	8.33Hz	8.28 Hz
Net Charge (per pulse)	0µC @ 500Ω	1.43µC @ 500Ω
Maximum Phase Charge	24.18µC @ 500Ω	23.7µC @ 500Ω
Maximum Current Density	0.498mA/cm²@500Ω(Minimum Electrode ContactArea:0.81cm²)	0.514mA/cm²@500Ω(Minimum ElectrodeContact Area:0.771cm²)
Maximum Average PowerDensity	32.77µW/cm² @500Ω(Minimum Electrode ContactArea:0.81cm²)	99.05µW/cm² @500Ω(Minimum ElectrodeContact Area:0.771cm²)
Maximum Power Density	2005µW/cm²@10kΩ(MinimumElectrode Contact Area:0.81cm²)	1981µW/cm²@10kΩ(MinimumElectrode Contact Area:0.771cm²)
Elements of Comparison	Subject Device	Predicate Device
Burst Mode (i.e., pulse trains)	a. Pulses per burst	20	20
	b. Pulses per second	8.33	8.28
	c. Burst duration (seconds)	2.4	2.42
	d. Duty Cycle[line (b)xline (c)]	20	20
Contraction and Relaxation Time		Adjustable, due to different modes.	Adjustable, due to different modes.

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The RejuvatoneMD has similar technological characteristics with the predicate device in the product design, material, program mode and output waveform.

There are minor differences between the RejuvatoneMD device and the predicate device in the electrode size and subsequently the output characteristics including "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse Frequency", "Net Charge (per pulse)", "Maximum Average Current", "Maximum Phase Charge", "Maximum Current Density", "Maximum Average Power Density", and "Burst Mode (i.e., pulse trains)." The output specification of the RejuvatoneMD device is very close to the predicate device in these areas and within an acceptable range. Both the predicate device and the RejuvatoneMD device comply with IEC 60601-2-10 requirement. So the differences of function specification do not raise any safety or effectiveness issue and does not effect the determination of substantial equivalence.

7. Performance Testing and Standards:

Safety & performance testing demonstrates that the RejuvatoneMD is at least as safe and effective as the legally marketed predicate device.

The RejuvatoneMD device has been tested and conforms to international consensus standards:

ELECTRICAL SAFETY:

Recognition Number 19-4:

. IEC/EN 60601-1:2005 Edition 3/(R)2012 And A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (lec 60601-1:2005, Mod). (General II (ES/EMC))
PERFORMANCE: Recognition Number 17-11:

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IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. (Neurology)
EMC:

Recognition Number 19-1:

IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. (General II (ES/EMC))

LABEL VALIDATION:

A Usability/Label Comprehension Study was conducted in order to validate the device labeling with 30 participants.

The results of the final study group found that over 95% of the participants were able to:

Correctly Self-Select the device as the correct or incorrect device for themselves
Correctly complete the Comprehension portion of the study
Correctly perform the Device Use portion of the study

In addition to the testing above, the RejuvatoneMD was designed referencing the following standards and FDA Guidance documents:

USABILITY:

Recognition Number 5-85:

. IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for safety – Collateral Standard: Usability Edition 3.0, 2010
Recognition Number 5-67:
. IEC 62366:2007/(R)2013, Medical Devices - Application Of Usability Engineering To Medical Devices. (General I (QS/RM))

RISK MANAGEMENT:

Recognition Number 5-40:

ISO 14971:2007, ed.2 + MDD 93/42/EEC Annex I, IEC 60601-1, ed. 3+A1, Medical Devices -. Application Of Risk Management To Medical Devices. (General I (QS/RM))

SOFTWARE DESIGN:

Recognition Number 13-8:

. IEC 62304 First Edition 2006-05, Medical Device Software - Software Life Cycle Processes. (Software/Informatics)
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005; and
General Principles of Software Validation: Final Guidance for Industry and FDA Staff, January 11, 2002

8. Substantial Equivalence Conclusion

After an analysis of the safety, indications, intended uses, performance features, design materials,

biocompatibility, power output, technological properties, treatment regimes and

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methods of operation, the Sponsor believes that no significant differences exist between the device and the predicate device. Minor differences in the technological characteristics of the RejuvatoneMD device and the predicate devices do not raise any issues of safety or effectiveness Therefore substantial equivalency is requested.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).